YY/T 1735-2021Hepatitis C virus antibody (anti-HCV) detection reagent (kit) (chemiluminescent immunoassay) (English PDF)
丙型肝炎病毒抗体检测试剂（盒）（化学发光免疫分析法）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 9, 2021
Implementation date
April 1, 2022
Scope
YY/T 1735-2021 is the English-translated version of 丙型肝炎病毒抗体检测试剂（盒）（化学发光免疫分析法）.
YY/T 1735-2021 is the Chinese pharmaceutical industry standard for kits that detect antibody to hepatitis C virus by chemiluminescence.
It sets the requirements, the test methods, the labels and marks, the instructions for use and the rules for packaging, transport and storage, the requirements covering appearance, the agreement with national reference panels for the negative and positive results, the detection limit, precision and stability.
It applies to kits for the qualitative detection of anti-HCV in human serum and plasma, whether the format is indirect or double-antigen sandwich, and whether the signal is chemiluminescent, electrochemiluminescent or time-resolved fluorescence. Issued on 9 March 2021, it has applied since 1 April 2022.
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Document preview — YY/T 1735-2021
National Standard of the People's Republic of China
- Classification
- C 44
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Requirements
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
1 Scope
This standard specifies the requirements, test methods, labels, and labels of hepatitis C virus antibody detection reagents (kits) (chemiluminescence immunoassay). Signs, instructions for use, packaging, transportation and storage, etc.
This standard is applicable to the qualitative detection of C in human serum and plasma using the principle of chemiluminescence analysis using indirect method or double antigen sandwich method.
Hepatitis B virus antibody detection kit (kit). Including chemiluminescence, electrochemiluminescence and time-resolved fluorescence methods. This standard does not apply to.
a) Hepatitis C virus antibody calibrators and hepatitis C virus antibody quality control products that are intended to be sold separately;
b) A biochip based on the principle of chemiluminescence immunoassay.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated reference documents, the latest version (including all amendments) is applicable to this document.
GB/T 191 Packaging, storage and transportation pictorial signs
GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2: In vitro diagnostic reagents for professional use
3 Requirements
3.1 Appearance
The appearance should meet the following requirements.
a) Each component of the reagent (kit) should be complete and complete, and there should be no leakage of liquid;
b) Chinese packaging labels should be clear and free from wear.
3.2 Compliance rate of positive reference products
Use the national reference material or the positive reference material standardized by the national reference material for verification, and the conformity rate of the positive reference material should meet the corresponding requirements.
Please refer to Appendix A for information on national reference materials for hepatitis C virus antibodies. The following clauses are similar.
3.3 Compliance rate of negative reference products
Use the national reference material or the negative reference material standardized by the national reference material for verification, and the compliance rate of the negative reference material should meet the corresponding requirements.
3.4 The lowest detection limit
Use the national reference product or the lowest detection limit reference product standardized by the national reference product for verification, and the minimum detection limit should meet the corresponding requirements.
3.5 Repeatability
Use a national reference product or a precision reference product standardized by a national reference product for verification, and perform parallel testing for 10 times. The coefficient of variation (CV) should be
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 21 pages — is available in the English PDF.
Referenced standards
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Related Standards
GB/T 191-2025 — Graphical symbols marking for handling and storage of packages
GB/T 29791.2-2013 — In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 2: In vitro diagnostic reagents for professional use
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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